Yesterday CMS posted a Final Decision Memorandum for the Expedited Removal of National Coverage Determinations (NCDs). By way of background, in an August 7, 2013 Federal Register notice (78 FR 48164), CMS established an expedited process for removing NCDs under certain circumstances, such as when they are no longer contain clinically pertinent or when the items or services are used infrequently by beneficiaries. Removal of an NCD does not necessarily result in noncoverage; instead, it allows the local Medicare Administrative Contractors (MACs) to determine coverage.
CMS reviewed NCDs that have not been reviewed in 10 years in order to evaluate the continued need for those policies to remain active on a national scale, and on November 27, 2013 CMS published for public comment the first list of NCDs proposed for removal. After review of public comments, CMS is now removing the following NCDs from the NCD Manual, effective December 18, 2014:Continue Reading...
CMS has announced its detailed timeline for recompeting the supplier contracts awarded under Round 2 of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program and the National Mail-Order diabetic testing supplies competition. All current Round 2 and National Mail-Order diabetic testing supplies contracts will be up for rebidding. The current contract period expires on June 30, 2016; the new contracts will begin on July 1, 2016. The first key date in the recompete cycle is December 18, 2014, when supplier registration for bidding opens, and the actual bid window opens on January 22, 2015. The full timeline is as follows (note that dates are subject to change):Continue Reading...
CMS has posted the January 2015 update to the Medicare average sales price (ASP) drug pricing files, which contain the payment amounts that CMS will use to pay for Part B covered drugs for the first quarter of 2015. CMS notes that prices for the top Part B drugs decreased by 0.1 % on average this quarter, and prices changed 2% or less for 26 of the top 50 higher-volume drugs.
CMS has announced that it is delaying a provision of its 2015 Medicare Advantage/Medicare Part D final rule, published on May 23, 2014, that requires physicians and other eligible professionals who prescribe Part D drugs to be enrolled in Medicare (or have a valid opt-out affidavit on file) for their prescriptions to be covered under Medicare Part D. While the final rule stated that the effective date for this requirement would be June 1, 2015, CMS has announced that it is delaying enforcement of this provision until December 1, 2015. CMS notes that Part D drug prescribers must submit their Medicare enrollment applications or opt-out affidavits to their Medicare Administrative Contractors by June 1, 2015 to provide sufficient processing time and prevent prescription drug claims from being denied beginning December 1, 2015.
On November 20, 2014, CMS released its final Medicare coverage document entitled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development.” CED policy provides the framework for Medicare coverage of items or services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CMS notes that the CED process “can expedite earlier beneficiary access to innovative technology while ensuring that systematic patient safeguards” are in place. The final guidance describes, among other things, the history of CED, its statutory basis, governing principles, requirements for studies under the CED framework, coverage of control groups in CED studies, and transparency of such studies. CMS also responds to public comments received on a draft guidance document published on November 12, 2012. For instance, CMS notes that it has deleted a previous statement that it expects to use CED infrequently, since technology is being presented to the agency for coverage earlier in the technology lifecycle, and requesters more frequently ask CMS to consider using CED for their particular technology. CMS also agrees with commenters that CED should not be used when other forms of coverage are justified, should not duplicate efforts of other agencies or existing medical evidence, and should generally expand access to technologies. CMS also clarified that Medicare Administrative Contractors may use LCDs to determine coverage of items and services to the extent that they do not conflict with national Medicare policy.
CMS has announced that while it still has no fixed date for releasing finalized Affordable Care Act (ACA) federal upper limits (FUL) for multiple source prescription drugs, it intends to release the finalized ACA FULs at or about the same time that it publishes a final rule pertaining to Medicaid reimbursement for covered outpatient drugs under the ACA. According to the latest unified agenda, CMS now expects to issue that rulemaking in April 2015. In the interim, CMS will continue to post the draft monthly ACA FUL files.
CMS has released the Medicare DMEPOS fee schedule files that are effective January 1, 2015. The DMEPOS fee schedule update factor for 2015 is 1.5%.
In mid-2014, state survey agencies and CMS piloted a short-term focused survey in five states to assess nursing home Minimum Data Set, Version 3.0 (MDS 3.0) coding practices and its relationship to resident care. According to a CMS memo to state survey agencies, these surveys enhanced surveyors’ ability to identify errors and deficiencies, such as inaccuracies related to staging and documentation of pressure ulcers, the classification of antipsychotic drugs, and coding regarding the use of restraints. CMS therefore announced that it plans to expand these surveys nationwide in 2015. The scope of some or all of the focused surveys also will be expanded to include an assessment of the staffing levels of nursing facilities. Specifically, the assessment is intended to verify the staffing data self-reported by the nursing home and identify changes in staffing levels throughout the year.
CMS has announced that the CY 2015 Medicare outpatient therapy limit is $1,940 for physical therapy and speech-language pathology combined and $1,940 for occupational therapy. The therapy cap exceptions process was extended through March 31, 2015 by the Protecting Access to Medicare Act of 2014.
CMS has announced that it is delaying until further notice enforcement of its regulations pertaining to health plan enumeration and use of the Health Plan Identifier (HPID) in HIPAA transactions, which were adopted in a September 5, 2012 final rule. This enforcement delay, which is effective October 31, 2014, applies to all HIPAA covered entities, including healthcare providers, health plans, and healthcare clearinghouses. This enforcement discretion period will allow HHS to consider recent recommendations by the National Committee on Vital and Health Statistics (NCVHS) that covered entities not use the HPID in the HIPAA transactions.
This post was written by Vicki Morris.
The Food and Drug Administration (FDA) recently issued a notice announcing the Agency’s revised guidance for industry defining the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The revised guidance, entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” follows the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which added a provision (and teeth) to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that render a drug “adulterated” – a new term used by the FDA in this context. Specifically, a drug adulterated under FDASIA “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” FDA issued the revised guidance in response to comments on the Agency’s draft guidance for industry of the same title issued in July 2013.
The revised guidance clarifies FDA’s expectations regarding the types of action, inaction, and circumstances that make a drug adulterated under FDASIA and the FD&C Act. FDA also provides examples that constitute reasonable explanations for actions, inactions, or circumstances that could otherwise be considered delaying, denying or limiting inspection, or refusing to permit entry or inspection, as discussed below.Continue Reading...
CMS has announced its newest innovative delivery reform program, called the “Transforming Clinical Practice Initiative,” which will provide up to $840 million over four years to help clinicians share, adapt, and develop quality improvement strategies. CMS intends to make awards for the following two types of systems:
- Practice Transformation Networks are peer-based learning networks designed to help clinicians develop core competencies specific to practice transformation. CMS is seeking applicants that have pre-existing relationships with multiple clinician practices that include data sharing capabilities (e.g., health systems; regional extension centers; quality improvement organizations; large group practices; regional/state-based health collaboratives; and hospital systems).
- Support and Alignment Networks will promote workforce development through organizations that use tools such as continuing medical education, maintenance of certification, and core competency development to help ensure sustainability of these efforts. Applicants could include medical professional associations, specialty societies, and organizations that generate evidence-based clinical practice guidelines, support efforts to reduce unnecessary testing and procedures, and effectively incorporate safety and patient/family engagement.
Applicants are encouraged to submit a letter of intent by November 20, 2014, and applications are due by January 6, 2015. CMS anticipates announcing awards in spring/summer 2015.
CMS has announced a new Accountable Care Organization “Investment Model” that was developed in response to concerns that some providers lack adequate access to the capital needed to invest in infrastructure necessary to successfully implement population care management. CMS will provide as much as $114 million in upfront investments to up to 75 ACOs across the country to help these ACOs make infrastructure investments and develop new ways to improve care for Medicare beneficiaries.
CMS is inviting quality measure suggestions for potential use in the Physician Quality Reporting System (PQRS) and other physician quality programs. Measure suggestions will be accepted on an ongoing basis, with measures submitted prior to June 15, 2015 eligible to be considered for inclusion in the PQRS as early as 2017.
CMS has posted the 2015 Medicare Star Ratings for Medicare Advantage (MA) and Medicare Part D prescription drug plans (PDPs). According to a CMS fact sheet, there are increases in the number of Medicare beneficiaries in high-performing MA plans and PDPs for 2015, while CMS notes “dramatic improvement” among plans that had received the low performing icon in 2014. CMS also is interested in receiving information from the public regarding potential data differences in MA and Part D quality measurements for dual-eligible versus non-dual-eligible enrollees. Information is due November 3, 2014. Finally, CMS has released the MA and PDP annual audit and enforcement report for 2013. According to the report, CMS imposed 43 CMPs totaling almost $8.4 million on 39 different organizations and 5 cases of immediate suspension of enrollment and marketing activities for issues identified in 2012 and 2013. Most violations cited in enforcement actions related to inappropriate delays or denials of access to health services and medications for enrollees.
As previously reported, CMS is offering an "administrative agreement" providing partial payment to hospitals that drop their appeals related to certain short-stay hospital claims in an effort to reduce the backlog in Medicare appeals. CMS has posted updated “frequently asked questions” on its proposed settlement process. The deadline for applying for the settlement is October 31, 2014, but providers may request an extension if they are not able to meet this deadline.
CMS has released a beta version of its Open Payments search tool, which is intended to facilitate public review of payments and transfers of value made by drug and device manufacturers and group purchasing organization (GPOs) to physicians and teaching hospitals, as well as physician ownership information. The tool allows the public to search identified data for physicians, teaching hospitals, or companies. CMS is also reminding applicable manufacturers and GPOs of an October 31, 2014 deadline for making corrections to any 2013 Open Payments disputed records for publication on or before December 31, 2014 (although data corrections can be performed at any time). Disputes that remain unresolved as of October 31, 2014 will display as disputed in the Open Payments database.
CMS has posted its preliminary payment determinations for new 2015 clinical laboratory fee schedule codes. The document lists CMS’s recommendation regarding the basis of payment for codes -- either crosswalk or gap-fill. Note that CMS is recommending to delay pricing various individual drug testing screening codes given “the potential for overpayment when billing for each individual drug test rather than a single code that pays the same regardless of the number of drugs that are being tested for.” Additional information about the comment and reconsideration process is available on the CMS website.